MumCare: Mum's Cardiovascular Health for Life

NCT ID: NCT05835596

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-18
• Study Completion Date: 2029-09-30

Brief Summary

The goal of this randomized clinical trial study is to test the potential benefits of eHealth-assisted follow-up after pregnancy complications that confer and increased risk for premature cardiovascular (CV) disease.

The overarching aim is to improve short- and long-term CV health in women following pregnancy complications associated with increased risk of CV disease (hypertensive disorders of pregnancy and gestational diabetes). The investigators will develop and test a novel, personalized and user co-designed digital eHealth companion ("app") and test the app in a clinical randomized control trial. The group randomized to app use will get access to the app prior to delivery or within the first weeks postpartum, whereas the control group will not get access to the app, but receive ordinary follow-up. Both groups are invited to a comprehensive cardiovascular follow-up 14-18 months post delivery.

The primary objective is to assess whether the rate of 1-year postpartum follow-up at the general practitioner's is increased with MumCare app access. Secondary objectives are to assess:

1. expectations of (and satisfaction with) postpartum eHealth-assisted technologies,

2. if health perception, sense of empowerment, quality of life, modifiable risk factors for CV disease (including hypertension, dyslipidemia, blood sugar control, smoking, weight), CV findings (including non-invasive hemodynamics) and biomarkers are affected by MumCare app use.

Detailed Description

Cardiovascular disease (CVD) is a leading cause of premature death and morbidity in women. CVD prevention is most effective when started at subclinical stages. Preeclampsia, gestational hypertension, and gestational diabetes are female sex-specific risk factors for CVD. Postpartum follow-up programs for the primary prevention of CVD following these complications are not offered today. In the MumCare study, a randomized control trial (RCT) will test a new eHealth app that promotes a personalized cardiovascular (CV) health optimization in young women after such pregnancy complications.

The study will first assess users' expectations of eHealth-assisted follow-up following the aforementioned pregnancy complications. These users will test and help fine-tune the new MumCare app, which integrates patient self-registered health data with an educational follow-up program based on Norwegian obstetric - and the Norwegian Directorate of Health guidelines. The study will recruit women to use the MumCare app in a 1:1 RCT lasting 18 months postpartum. App use (in the active study arm) will be registered in secure IT systems.

The primary outcome for comparison between groups (women with and without app access) is the rate of 1-year postpartum follow-up with a general practitioner (as recommended in the obstetric guidelines). Secondary outcomes include user-reported outcomes (such as health empowerment and quality of life) and objective risk factors for CVD (evaluated 14-18 months postpartum in all study groups, including assessment of CV risk factors, CV function and biomarkers).

Conditions

Hypertensive Disorder of Pregnancy; Preeclampsia; Gestational Hypertension; Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Access to MumCare app

Women will be randomized prospectively (before or after delivery) after they consent to participate in the study. These women are at increased risk of longterm cardiovascular disease due to hypertensive or gestational diabetes pregnancy complication. This group is randomized to have access to the MumCare app will, in addition to standard care, have access to the app for 14-18 months following giving birth. The MumCare app has 3 main parts (1. an educational part, 2. The patient's own health data (entered by the user herself) that represent modifiable risk factors for cardiovascular disease), and 3. The app will send push reminders for the woman to book a visit at her general practitioner according to recommended guidelines (that are usually not followed-up today).

All women in the study will be invited to a cardiovascular health evaluation at 14-18 months postpartum.

Group Type: ACTIVE_COMPARATOR

Access to MumCare app

Intervention Type: DEVICE

Education, push warning to book cardiovascular health follow-up at own general practitioner , registration of BP and lipids, HbAc

No access to MumCare app

Women will be prosepctively randomized (before or after delivery) after they consent to participate in the study. These women are at increased risk of longterm cardiovascular disease due to hypertensive or gestational diabetes pregnancy complication. Women randomized to NOT have access to the MumCare app will receive standard care, which includes being provided oral and written information according to delivery ward routines.

All women in the study will be invited to a cardiovascular health evaluation at 14-18 months postpartum.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Access to MumCare app

Education, push warning to book cardiovascular health follow-up at own general practitioner , registration of BP and lipids, HbAc

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• An ongoing or recent pregnancy complicated by hypertensive disorder of pregnancy and/or gestational diabetes mellitus
• Patient attending Oslo University Hospital, Oslo, Norway
• Signed informed written consent (to be randomized to app access or not)

Exclusion Criteria

• Not capable of accessing and using an app downloaded on a smart phone
• Not able to understand the informed consent or app instructions or content (in Norwegian, but later the study consent form and app will be translated into English and other languages)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Norwegian SIDS and Stillbirth Society

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Cathrine Staff

Professor and Head of research (Div. Obst and Gyn)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Cathrine Staff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

478376

Identifier Type: -

Identifier Source: org_study_id